Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06560255
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-15
Brief Title:
Fish Oil in pREgnancY for Personalized Prevention of Early Childhood Asthma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Fish Oil in pREgnancY for Personalized Prevention of Early Childhood Asthma FREYA
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FREYA
Brief Summary:
The overall aim of the study is to develop a nutritional preventive fish oil supplementation strategy in pregnancy for early childhood asthmapersistent wheeze during the first three years of life as we hypothesize that both supplementations in higher doses than recommended could reduce the risk of disease development
Detailed Description:
Randomization of 2000 pregnant women to fish oil of 24 gday 55 EPA and 37 DHA in triacylglycerol form vs placebo Supplementation begins in gestational week 24 22-26 until 1 week after delivery Allocation to the trial will be determined based on the pre-interventional maternal blood levels of EPADHA with a dried blood screening test Women with low levels below 47 of total fatty acids will be assigned to the fish oil RCT Maternal blood will be used for genetic metabolomic and proteomic profiling A 3-year follow-up of the children with longitudinal registration of parent reported symptoms diagnoses medication use and hospitalizations will be performed The primary outcome is persistent wheeze or asthma until age 3 years with predefined analyses of effect modification by maternal genotypes Secondary outcomes are lower respiratory tract infections gastrointestinal infections croup troublesome lung symptoms eczema allergy bone fractures developmental milestones mental health cognition and growth until age 3 years A follow-up on both primary and secondary outcomes is planned after unblinding from age 3 to 6 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None